This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Navidea Biopharmaceuticals Announces Agreement With FDA On Special Protocol Assessments For NAV5001 Phase 3 Program

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) for two special protocol assessments (SPA) for the Company’s pivotal Phase 3 program with NAV5001 as an aid in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor. NAV5001 is an investigational imaging agent used to visualize dopamine transporters (DAT) in the brain using single photon emission tomography (SPECT) imaging. The SPAs are written agreements between the Company, as the program’s sponsor, and FDA regarding the design, endpoints and statistical analysis for the two pivotal Phase 3 clinical trials to be used in support of a potential NAV5001 New Drug Application (NDA). The Company is actively preparing for the initiation of the pivotal Phase 3 trials later this year.

“Reaching an agreement on the SPAs indicates that FDA considers the design of the program and positive results from the Phase 3 trials will be appropriate for FDA consideration for regulatory approval of NAV5001 as an aid in the diagnosis of Parkinsonian syndromes,” said William J. Regan, Navidea Senior Vice President, Global Regulatory Strategy. “In achieving the SPA agreements on a first-cycle review, we are extremely pleased to have more certainty around FDA registration requirements.”

The international, open-label, pivotal NAV5001 Phase 3 program consists of two similar clinical trials that will run in parallel and enroll approximately 550 total subjects who exhibit early stage tremor. Each Phase 3 trial was the subject of a SPA with FDA. The primary endpoint of both studies is to evaluate the relative diagnostic efficacy of the NAV5001 SPECT images compared with the diagnosis made by neurologists and that established by a consensus panel of three movement disorder specialists as the ‘Standard of Truth’. In one study, each subject will undergo SPECT imaging with NAV5001 only. In the second study, subjects will undergo SPECT imaging with both NAV5001 and an alternative SPECT agent, ioflupane, in a cross-over comparison design.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $95.37 1.80%
FB $117.76 -0.68%
GOOG $696.03 -0.31%
TSLA $233.30 -3.50%
YHOO $36.11 -1.10%


Chart of I:DJI
DOW 17,769.98 -121.18 -0.68%
S&P 500 2,064.04 -17.39 -0.84%
NASDAQ 4,773.0850 -44.5090 -0.92%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs